Effect of Oral Ice Chips to Prevent Chemotherapy-Induced Oral Mucositis in Patient With Solid Tumor Treated With 5 Fluorouracil and Methotrexate

The goal of this randomized controlled clinical trial is to determine whether oral cryotherapy using ice chips can prevent and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients receiving 5-fluorouracil and methotrexate chemotherapy regimens. The main questions it aims to answer are: Does the application of oral ice chips reduce the severity of oral mucositis compared to routine mouth care alone? Is there a significant difference in oral mucositis grades between patients receiving oral cryotherapy and those receiving standard mouthwash care? Researchers will compare the experimental group receiving oral ice chips during chemotherapy plus routine mouthwash care with the control group receiving routine mouthwash care only to evaluate the effectiveness of oral cryotherapy in reducing oral mucositis severity. Participants will: Be randomly assigned to either the experimental group (n = 51) or control group (n = 51) Receive chemotherapy with 5-fluorouracil or methotrexate Use routine mouthwash (normal saline/sodium bicarbonate/chlorhexidine) at home Receive oral ice chips during chemotherapy infusion (experimental group only) Be assessed for oral mucositis severity using the WHO Oral Mucositis Grading Scale before and after the intervention

NCT Number	NCT07327476
Lead Sponsor	University of Health Sciences Lahore
Conditions	Chemotherapy Induced Oral Mucositis
Enrollment	102 participants
Start Date	2026-07-15
Primary Completion	2026-10-30 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-16